RxSight Light Adjustable Lens (RxLAL) 60005-3175Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00818806020623), received between Dec 9, 2022 and Apr 24, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Optical Decentration; Material Twisted/Bent

  A SITE REPORTED TO RXSIGHT THAT A PATIENT UNDERWENT PRIMARY CATARACT SURGERY DURING WHICH A LIGHT ADJUSTABLE LENS (LAL) WAS IMPLANTED. APPROXIMATELY THREE WEEKS FOLLOWING THE INITIAL IMPLANTATION, THE LAL WAS EXPLANTED DUE TO LENS DISLOCATION, REPORTEDLY RESULTING FROM A BENT HAPTIC. A NEW LAL WAS SUBSEQUENTLY IMPLANTED AS A REPLACEMENT. POSTOPERATIVELY, THE LENS WAS REPORTED TO BE CENTERED IN THE SULCUS. SEPARATELY, AND NOT RELATED TO AN RXSIGHT DEVICE, THE SITE REPORTED THAT A CAPSULAR TEAR OCCURRED DURING THE PRIMARY CATARACT SURGERY. AN ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED APPROXIMATELY ONE WEEK AFTER THE PRIMARY CATARACT SURGERY TO COMPLETE A VITRECTOMY WITH REMOVAL OF LENS FRAGMENTS. THE REPORTER DID NOT INDICATE WHETHER THE CAPSULAR TEAR OR SUBSEQUENT VITRECTOMY CONTRIBUTED TO THE REPORTED LENS DISLOCATION.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24989594 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 24879074 ↗
• InjuryMar 4, 2026Device Dislodged or Dislocated

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WITH HISTORY OF TRAUMATIC CATARACT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.5D) AS A REPLACEMENT FOR A MONOFOCAL LENS FROM ANOTHER MANUFACTURER THAT HAD DISLOCATED. POST-OPERATIVELY, THE LAL WAS OBSERVED TO BE DISLOCATED INTO THE POSTERIOR POLE. ON (B)(6) 2026, THE LAL WAS EXPLANTED AND A NEW LAL (SN (B)(6), +17.5D) WAS IMPLANTED VIA YAMANE TECHNIQUE AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 24506893 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS ((B)(6), +17.5D) WAS IMPLANTED BACKWARDS IN THE RIGHT EYE ON (B)(6) 2025. THE LENS WAS SUCCESSFULLY FLIPPED TO THE CORRECT ORIENTATION DURING A SECONDARY SURGERY ON (B)(6) 2026. DUE TO INSTABILITY OF THE CAPSULAR BAG AND ZONULES, THE LAL WAS PLACED IN THE SULCUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378547 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.50D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 24274182 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.0D) WAS EXPLANTED DUE TO THE PATIENT'S INABILITY TO ADEQUATELY DILATE FOR LIGHT TREATMENTS SECONDARY TO INTRAOPERATIVE FLOPPY IRIS SYNDROME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779728 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, (B)(6), +17.5D) WAS EXPLANTED DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 22342663 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.5D) WAS EXPLANTED FOLLOWING LIGHT TREATMENTS DUE TO HYPEROPIC REFRACTIVE OUTCOME.

  Patient problems: Blurred Vision

  MAUDE report 22135370 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.5D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO PATIENT EXPERIENCING VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 20880813 ↗
• InjuryOct 16, 2024Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.5D) WAS IMPLANTED ON (B)(6) 2022. NO LIGHT TREATMENTS WERE PERFORMED AND THE PATIENT SELF-REPORTED NOT WEARING RXSIGHT UV SPECTACLES DURING THE POST-OPERATIVE PERIOD. APPROXIMATELY 2 YEARS AND 5 MONTHS FOLLOWING IMPLANTATION, THE PATIENT PRESENTED TO THE CLINIC WITH BLURRY VISION AND GLARE, AND A RAISED AREA WAS OBSERVED ON THE LENS, CONSISTENT WITH ZONE FORMATION. THE LAL WAS EXPLANTED ON (B)(6) 2024, AND AN INTRAOCULAR LENS (IOL) FROM A DIFFERENT MANUFACTURER WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20467347 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE (LAL, SN (B)(6), +17.5D) WAS EXPLANTED FROM THE LEFT EYE DUE TO BLURRED VISION AND DIPLOPIA. A NEW LAL (SN (B)(6), +18.0D) WAS IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 06/27/2024. REFERENCE REPORT #3012712027-2024-00135 FOR THE REPORT ON THE RIGHT EYE.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 19987008 ↗
• InjuryJun 15, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED, TO RXSIGHT. THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN#: (B)(6) +17.5D) WAS EXPLANTED FROM THE LEFT EYE (OS). AND A NEW LIGHT ADJUSTABLE LENS+ (LAL+, SN#: (B)(6) +18.0D) WAS IMPLANTED AS A REPLACEMENT, DUE TO REDUCED UNCORRECTED DISTANCE VISION WITH -1.75 MANIFEST REFRACTION (MR). FOLLOWING TWO LIGHT TREATMENTS ON THE NEW LAL+. UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) WAS 20/40, WITH A MR OF -0.75.

  Patient problems: Blurred Vision

  MAUDE report 19543998 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO RXSIGHT, THE PATIENT HAD A "DENSE WHITE CATARACT WITH NO VIEW TO THE BACK" AND THE POSTERIOR CAPSULE WAS RUPTURED PRIOR TO DELIVERY OF THE LAL INTO THE EYE. DUE TO THE RUPTURED CAPSULE, THE LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +17.5D) WAS PLACED IN THE SULCUS. DURING THE POST-OP PERIOD, THE LAL WAS NOTED TO BE DISPLACED DUE TO LIKELY ZONULAR DAMAGE. THE DECISION WAS MADE TO EXPLANT THE LAL AND AN IOL OF A DIFFERENT MANUFACTURER WAS IMPLANTED WITH SCLERAL FIXATION. A PARS PLANA VITRECTOMY WAS ALSO PERFORMED DURING THE EXPLANT SURGERY. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 18166247 ↗
• InjuryNov 9, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +17.5D) WAS EXPLANTED ON (B)(6) 2023, AND REPLACED WITH ANOTHER LAL (SN: (B)(6), +13.0D) DUE TO A REFRACTIVE SURPRISE AFTER PRIMARY IMPLANT SURGERY AND BEFORE ANY LIGHT TREATMENTS WERE PERFORMED. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON OCTOBER 11, 2023.

  Patient problems: Visual Impairment

  MAUDE report 18107396 ↗
• InjurySep 15, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) , +17.5D) WAS EXPLANTED ON (B)(6) 2023 DUE TO THE LENS BEING IMPLANTED BACKWARD DURING THE CATARACT SURGERY. THE ORIGINAL LAL WAS REPLACED WITH ANOTHER LAL OF THE SAME DIOPTER. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6) 2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17760687 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A BILATERALLY IMPLANTED PATIENT HAD A LIGHT ADJUSTABLE LENS (LAL SN (B)(6)) EXPLANTED FROM HER RIGHT EYE (OD) DUE TO BEING DISSATISFIED WITH THE OUTCOME. REFERENCE MDR 3012712027-2023-00065 FOR THE REPORT ON THE LEFT EYE (OS).

  Patient problems: Visual Impairment

  MAUDE report 17313191 ↗
• InjuryMay 17, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6)) WAS EXPLANTED DUE TO THE PATIENT HAVING AN UNEXPECTED REFRACTIVE OUTCOME POST IMPLANTATION AND PRIOR TO ANY LIGHT TREATMENTS. THE INITIAL LAL WAS EXPLANTED ON (B)(6) 2023, AND WAS REPLACED WITH ANOTHER LAL (SN (B)(6)). RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 16949770 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), 17.5D) WAS EXPLANTED. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON (B)(6)2023.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 16916496 ↗
• InjuryDec 9, 2022Optical Problem; Optical Problem

  THE SITE REPORTED THAT A LIGHT ADJUSTABLE LENS (LAL) WAS EXPLANTED AND REPLACED WITH ANOTHER LAL. THE EXPLANTED LAL (B)(4) WAS 17.5D. THE SECOND LAL (B)(4) WAS 20.5D. RXSIGHT'S FIRST AWARENESS OF THE EVENT WAS ON (B)(6) 2022.

  Patient problems: Visual Impairment

  MAUDE report 15955734 ↗